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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892953
Device Name PATIENT EXAMINATION GLOVES
Applicant
Masju Sdn. Bhd.
Plot 3, Jalan 1, Tikam Batu
Sungai Petani,  MY 08600
Applicant Contact CHENG HUI
Correspondent
Masju Sdn. Bhd.
Plot 3, Jalan 1, Tikam Batu
Sungai Petani,  MY 08600
Correspondent Contact CHENG HUI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 09/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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